Anakinra for Asthma

(ARTMA Trial)

Overseen By Corinne Taylor

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of North Carolina, Chapel Hill

Must be taking: Inhaled corticosteroids, Long-acting beta agonists

Must not be taking: Systemic corticosteroids, Immunomodulatory therapy

Disqualifiers: Chronic pulmonary disease, Smoking, Diabetes, others

Compensation: Varies

Number of Visits: 3

Duration: 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests anakinra, a medication, to determine its effectiveness for people with asthma during moderate flare-ups. Participants will receive either anakinra or a placebo (a harmless pill with no active drug) to compare results. The goal is to assess whether anakinra can effectively manage asthma symptoms and guide future studies. Suitable candidates have had asthma for over a year, have used inhalers or similar treatments, and have required oral steroids for asthma in the past year. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering a unique opportunity to be among the first to receive this treatment.

Is there any evidence suggesting that anakinra is likely to be safe for humans?

Previous studies have shown that anakinra is safe and well-tolerated in various conditions. For instance, in patients with rheumatoid arthritis, anakinra had a similar rate of serious side effects as a placebo, indicating no more serious problems than a sugar pill. Another study on anakinra for Sanfilippo syndrome found no serious side effects linked to the drug.

Additionally, in a study simulating lung inflammation, anakinra reduced inflammation without causing serious side effects. This suggests that anakinra can be safe for treating breathing issues. Overall, these findings indicate that anakinra might be safe for use in humans, including those with asthma. However, since this trial is in its early stages, it focuses on gathering more safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Most treatments for asthma focus on controlling symptoms with medications like inhaled corticosteroids or bronchodilators. But anakinra works differently, targeting inflammation at its source. Anakinra blocks a specific protein in the body called interleukin-1, which plays a key role in inflammation. This approach could offer a new way to prevent asthma exacerbations, potentially reducing reliance on traditional symptom management methods. Researchers are excited because this could mean fewer flare-ups and improved quality of life for asthma patients.

What evidence suggests that anakinra might be an effective treatment for asthma?

Research has shown that anakinra can help reduce inflammation related to asthma. In studies, anakinra significantly lowered airway inflammation without causing serious side effects. This is important because airway inflammation plays a major role in worsening asthma. Additionally, anakinra has shown potential in managing allergic inflammation, which often occurs with asthma. In this trial, participants will receive either anakinra or a placebo upon meeting specific exacerbation criteria. These findings suggest that anakinra might help control asthma flare-ups by addressing the underlying inflammation. ^{1 2 4 6 7}

Who Is on the Research Team?

Michelle Hernandez, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for people with asthma who are at high risk of having future asthma attacks. Participants must be able to follow a home treatment plan and will be monitored during their first moderate asthma attack over about six months.

Inclusion Criteria

Provision of signed and dated informed consent form

I am currently using inhaled corticosteroids or combination inhalers for my condition.

I have had a severe asthma attack needing steroid pills or shots in the past year.

Exclusion Criteria

Any chronic medical condition considered by the PI as a contraindication including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic or recurrent infections or immunodeficiency

Mental illness or history of substance abuse interfering with compliance

I have had bronchial thermoplasty in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive anakinra or placebo during a moderate asthma exacerbation, monitored for symptom scores, lung function, and medication use

10 days

Home administration with monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-treatment assessments for severe neutropenia and serious infections

14 days

2 visits (in-person)

Study Completion

Participants complete the study with final assessments and data collection

6 months

End of study visit

What Are the Treatments Tested in This Trial?

Interventions

• Anakinra

Trial Overview

The study tests whether anakinra, given by injection at home during a moderate asthma attack, can help as part of an asthma action plan compared to a placebo (saltwater) injection. Participants are randomly assigned to either group.

How Is the Trial Designed?

Group I: Active Treatment Active Control 1 Intervention

Subjects will be randomized to receive two doses of active study treatment (anakinra) upon meeting orange zone exacerbation criteria.

Group II: Placebo Placebo Group 1 Intervention

Subjects will be randomized to receive two doses of placebo upon meeting orange zone exacerbation criteria.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1.

publications.ersnet.org

publications.ersnet.org/content/erj/56/4/2000151

Real-world mepolizumab in the prospective severe asthma ...

Rates of clinically significant exacerbations were reduced by 69% from 4.63 per person per year pre-treatment to 1.43 per person per year during follow-up (p< ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03513471

Early Phase Administration of Anakinra as a Rescue ...

Purpose: The primary objective of this study is to examine the effectiveness of anakinra as a rescue treatment for allergic airway inflammation.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04035109

Anakinra as a Rescue Treatment for Allergic Inflammation

These data collectively suggest that IL-1 signaling is important in the allergic eosinophilic response and that anakinra has high potential to reduce ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4323893/

Interleukin-1 receptor antagonist reduces endotoxin-induced ...

Anakinra effectively reduced airway neutrophilic inflammation and resulted in no serious adverse events in a model of inhaled LPS challenge. Anakinra is a ...

5.

jacionline.org

jacionline.org/article/S0091-6749(14)01043-4/fulltext

IL-1 receptor antagonist reduces endotoxin-induced airway ...

Anakinra effectively reduced airway neutrophilic inflammation and resulted in no serious adverse events in a model of inhaled LPS challenge. Anakinra is a ...

6.

hopkinsarthritis.org

hopkinsarthritis.org/arthritis-news/anakinra-kineret-is-safe-and-well-tolerated-in-ra-patients-with-comorbid-conditions-from-johns-hopkins-arthritis/

Anakinra (Kineret) is Safe and Well Tolerated in RA ...

Results: These data represent the first six months of the study. Serious adverse events occurred at a similar rate in the anakinra and placebo ...

7.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2803480

Efficacy and Safety of Anakinra Plus Standard of Care for ...

This study did not find evidence of effectiveness of anakinra vs the standard of care in reducing the need for mechanical ventilation among patients with ...